Immunogenicity of fractional doses of tetravalent A/C/Y/W135 meningococcal polysaccharide vaccine: Results from a randomized non-inferiority controlled trial in Uganda

PLoS Neglected Tropical Diseases

Volumn 2, Issue 12, 2008, Pages

  Guerin, Philippe J ^a,b,c   Næss, Lisbeth M ^b,c   Fogg, Carole ^a   Rosenqvist, Einar ^b,c   Pinoges, Loretxu ^a   Bajunirwe, Francis ^a,d   Nabasumba, Carolyn ^a   Borrow, Ray ^e   Frøholm, Leif O ^b   Ghabri, Salah ^a   Batwala, Vincent ^a,d   Twesigye, Rogers ^a   Aaberge, Ingeborg S ^b,c   Røttingen, John Arne ^b,c,f   Piola, Patrice ^a   Caugant, Dominique A ^b,c  

^a EPICENTRE   (France)

^b NORWEGIAN INSTITUTE OF PUBLIC HEALTH   (Norway)

^c UNIVERSITY OF OSLO   (Norway)

^d MBARARA UNIVERSITY OF SCIENCE AND TECHNOLOGY   (Uganda)

^e PUBLIC HEALTH ENGLAND   (United Kingdom)

^f Norwegian Knowledge Centre for Health Services   (Norway)

Author keywords

[No Author keywords available]

Indexed keywords

MENINGOCOCCUS VACCINE; BACTERIAL POLYSACCHARIDE; BACTERIAL VACCINE; COMPLEMENT;

ADOLESCENT; ADULT; ARTICLE; CHILD; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG DOSE COMPARISON; DRUG DOSE REGIMEN; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; LABORATORY TEST; MAJOR CLINICAL STUDY; MALE; MENINGOCOCCOSIS; NEISSERIA MENINGITIDIS; RANDOMIZED CONTROLLED TRIAL; SERUM BACTERICIDAL ACTIVITY; SINGLE BLIND PROCEDURE; UGANDA; VACCINATION; VOLUNTEER; AFRICA SOUTH OF THE SAHARA; ANIMAL; DOSE RESPONSE; EPIDEMIC MENINGITIS; IMMUNOLOGY; PRESCHOOL CHILD; RABBIT; RADIATION DOSE FRACTIONATION; SAFETY;

ADOLESCENT; AFRICA SOUTH OF THE SAHARA; ANIMALS; BACTERIAL VACCINES; CHILD; CHILD, PRESCHOOL; COMPLEMENT SYSTEM PROTEINS; DOSE FRACTIONATION; DOSE-RESPONSE RELATIONSHIP, DRUG; HUMANS; MENINGITIS, MENINGOCOCCAL; NEISSERIA MENINGITIDIS; POLYSACCHARIDES, BACTERIAL; RABBITS; SAFETY; SINGLE-BLIND METHOD; UGANDA; YOUNG ADULT;

EID: 65549083873     PISSN: None     EISSN: None     Source Type: Journal    
DOI: 10.1371/journal.pntd.0000342     Document Type: Article

References (32)

1. Lapeyssonnie L (1968) [Comparative epidemiologic study of meningococcic cerebrospinal meningitis in temperate regions and in the meningitis belt in Africa. Attempt at synthesis]. Med Trop 28: 709-720.
2. World Health Organization (2000) Detecting meningococcal meningitis epidemics in highly-endemic African countries. Wkly Epidemiol Rec 75: 306-309.
3. Ouedraogo-Traore R, Hoiby EA, Sanou I, Sangare L, Kyelem N, et al. (2002) Molecular characteristics of Neisseria meningitidis strains isolated in Burkina Faso in 2001. Scand J Infect Dis 34: 804-807.
4. World Health Organization (2002) Meningococcal disease, serogroup W135, Burkina Faso. Wkly Epidemiol Rec 77: 152-155.
5. Zombre S, Hacen MM, Ouango G, Sanou S, Adamou Y, et al. (2007) The outbreak of meningitis due to Neisseria meningitidis W135 in 2003 in Burkina Faso and the national response: main lessons learnt. Vaccine 25 Suppl 1: A69-A71.
6. World Health Organization (2007) Risk of epidemic meningitis in Africa: a cause for concern. Wkly Epidemiol Rec 82: 79-87.
7. Greenwood B (2006) Editorial: 100 years of epidemic meningitis in West Africa-has anything changed? Trop Med Int Health 11: 773-780.
8. Jodar L, Feavers IM, Salisbury D, Granoff DM (2002) Development of vaccines against meningococcal disease. Lancet 359: 1499-1508.
9. LaForce FM, Konde K, Viviani S, Preziosi MP (2007) The Meningitis Vaccine Project. Vaccine 25 Suppl 1: A97-100.
10. Artenstein MS, Gold R, Zimmerly JG, Wyle FA, Branche WC Jr, et al. (1970) Cutaneous reactions and antibody response to meningococcal group C polysaccharide vaccines in man. J Infect Dis 121: 372-377.
11. Gold R, Lepow ML, Goldschneider I, Draper TL, Gotschlich EC (1975) Clinical evaluation of group A and group C meningococcal polysaccharide vaccines in infants. J Clin Invest 56: 1536-1547.
12. Griffiss JM, Brandt BL, Broud DD (1982) Human immune response to various doses of group Y and W135 meningococcal polysaccharide vaccines. Infect Immun 37: 205-208.
13. Griffiss JM, Brandt BL, Broud DD, Altieri PL, Berman SL (1985) Relationship of dose to the reactogenicity and immunogenicity of meningococcal polysaccharide vaccines in adults. Mil Med 150: 529-533.
14. Brandt BL, Griffiss JM, Broud DD, Boslego JW (1988) Tetravalent meningococcal polysaccharide vaccine. Relashionship of dose to immunogenicity and reactogenicity in young adults. In: Kluwer Academic Publishers, editors. Gonococci and Meningococci. Dordrecht, The Netherlands. pp 33-37.
15. Campagne G, Schuchat A, Djibo S, Ousseini A, Cisse L, et al. (1999) Epidemiology of bacterial meningitis in Niamey, Niger, 1981-96. Bull World Health Organ 77: 499-508.
16. Lellouch J, Lazar P (1974) Méthodes statistiques en expérimentation biologique. Paris, Flammarion.
17. Borrow R, Carlone GM (2001) Serogroup B and C serum bactericidal assays. In: Pollard AJ MMe, ed. Meningococcal vaccines: methods and protocols. Methods in molecular medicine. Totowa (New Jersey): Humana Press. pp 289-304.
18. Carlone GM, Frasch CE, Siber GR, Quataert S, Gheesling LL, et al. (1992) Multicenter comparison of levels of antibody to the Neisseria meningitidis group A capsular polysaccharide measured by using an enzyme-linked immunosorbent assay. J Clin Microbiol 30: 154-159.
19. Joseph H, Balmer P, Bybel M, Papa T, Ryall R, et al. (2004) Assignment of Neisseria meningitidis serogroups A, C, W135, and Y anticapsular total immunoglobulin G (IgG), IgG1, and IgG2 concentrations to reference sera. Clin Diagn Lab Immunol 11: 1-5.
20. Caugant DA, Fogg C, Bajunirwe F, Piola P, Twesigye R, et al. (2006) Pharyngeal carriage of Neisseria meningitidis in 2-19-year-old individuals in Uganda. Trans R Soc Trop Med Hyg 100: 1159-1163.
21. Andrews N, Borrow R, Miller E (2003) Validation of serological correlate of protection for meningococcal C conjugate vaccine by using efficacy estimates from postlicensure surveillance in England. Clin Diagn Lab Immunol 10: 780-786.
22. Goldschneider I, Gotschlich EC, Artenstein MS (1969) Human immunity to the meningococcus. I. The role of humoral antibodies. J Exp Med 129: 1307-1326.
23. Santos GF, Deck RR, Donnelly J, Blackwelder W, Granoff DM (2001) Importance of complement source in measuring meningococcal bactericidal titers. Clin Diagn Lab Immunol 8: 616-623.
24. Borrow R, Balmer P, Miller E (2005) Meningococcal surrogates of protection-serum bactericidal antibody activity. Vaccine 23: 2222-2227.
25. Jodar L, Stephens D, Feavers IM (2002) Assay parameters and methods of data analysis for the comparison of complement sources in the Neisseria meningitidis serogroup C serum bactericidal assay. Biologicals 30: 323-329.
26. Kayhty H, Karanko V, Peltola H, Sarna S, Makela PH (1980) Serum antibodies to capsular polysaccharide vaccine of group A Neissera meningitidis followed for three years in infants and children. J Infect Dis 142: 861-868.
27. Gold R, Artenstein MS (1971) Meningococcal infections. 2. Field trial of group C meningococcal polysaccharide vaccine in 1969-70. Bull World Health Organ 45: 279-282.
28. Yergeau A, Alain L, Pless R, Robert Y (1996) Adverse events temporally associated with meningococcal vaccines. CMAJ 154: 503-507.
29. Patel M, Lee CK (2005) Polysaccharide vaccines for preventing serogroup A meningococcal meningitis. Cochrane Database Syst Rev CD001093.
30. Joint United Nations Programme on HIV/AIDS (2008) Country situation analysis, Uganda. Available: http://www.unaids.org/en/CountryResponses/ Countries/Uganda.asp. Accessed 11 January 2008.
31. Meningococcal disease, Great Lakes area (Burundi, Rwanda, United Republic of Tanzania) - update (2002) Wkly Epidemiol Rec 77: 317.
32. Obaro SK, Ota MO (2006) Sense and the science of childhood immunization: can we achieve more with less? Vaccine 24: 6460-6467.